CN111228633A - A balloon catheter that partially blocks blood flow - Google Patents

Abstract

Translated fromChinese

本发明公开一种部分阻断血流的球囊导管，包括导管座和安装于导管座的管身，管身的远端节段上设置有多个球囊，管身内部设置有轴向延伸的主孔道和相互隔绝的多个侧孔道，导管座上对应设置有主管和多个侧管，多个侧孔道分别连通不同的球囊，以分别控制多个球囊的充气状态。通过多个球囊充气，有效对血栓近端血管进行不同程度的封堵阻断保护，以降低急性脑卒中开通后早期的血流大量灌注，减少再灌注损伤并发症，并通过独立调节多个球囊的充气状态，以实现对血管封闭状态的多级别准确调整，从而实现对灌注血流的精确控制，从而促进大脑功能恢复，无需使用繁多的辅助器械，单一器械即可实现术中血流阻滞造影评估和短期冲管及液体灌注。

The invention discloses a balloon catheter for partially blocking blood flow, comprising a catheter seat and a tube body mounted on the catheter seat, a plurality of balloons are arranged on the distal section of the tube body, and an axially extending tube is arranged inside the tube body The main channel and a plurality of side channels isolated from each other are correspondingly provided on the catheter holder with a main pipe and a plurality of side tubes, and the plurality of side channels are respectively connected with different balloons to respectively control the inflation state of the multiple balloons. By inflating multiple balloons, it can effectively block and block the proximal blood vessels of the thrombus to different degrees, so as to reduce the massive perfusion of blood in the early stage after the opening of acute stroke, and reduce the complications of reperfusion injury. The inflation state of the balloon can achieve multi-level accurate adjustment of the blood vessel sealing state, so as to achieve precise control of perfusion blood flow, thereby promoting the recovery of brain function, without the use of many auxiliary instruments, and a single instrument can achieve intraoperative blood flow Block angiographic assessment and short-term flushing and fluid perfusion.

Description

Translated fromChinese

一种部分阻断血流的球囊导管A balloon catheter that partially blocks blood flow

技术领域technical field

本发明涉及医疗设备领域，特别是涉及一种部分阻断血流的球囊导管。The invention relates to the field of medical equipment, in particular to a balloon catheter for partially blocking blood flow.

背景技术Background technique

介入治疗是介于外科、内科治疗之间的新兴治疗方法，经过多年的发展。脑血管疾病的介入技术作为一项具有代表性的微创治疗方式，近年来随着影像学设备的进步、新型介入器材的引入得以快速的发展。Interventional therapy is an emerging treatment method between surgery and medical treatment, after years of development. Interventional technology for cerebrovascular disease, as a representative minimally invasive treatment method, has developed rapidly in recent years with the advancement of imaging equipment and the introduction of new interventional equipment.

对于急性缺血性脑卒中的大血管闭塞的治疗，机械取栓法已逐步成为急性缺血性脑卒中治疗的亮点，它具有比静脉或动脉溶栓更高的血运重建率及更宽的时间窗，机械取栓法主要又分为两种，一是支架取栓法，该方法经股动脉穿刺，将导引导管系统推送到达卒中发病的动脉，然后通过微导管内腔将支架器械输送跨越血栓后，释放取栓支架，通过支架将血栓拉出从而帮助恢复血液流动，移除导致卒中的血栓；二是抽吸导管抽吸法，抽吸法通过将抽吸导管输送至卒中发病动脉的血栓近端，利用负压源将血栓或斑块从堵塞血管吸出清除，从而达到开通血管、恢复血流的目的。For the treatment of large vessel occlusion in acute ischemic stroke, mechanical thrombectomy has gradually become a bright spot in the treatment of acute ischemic stroke. It has a higher revascularization rate and a wider Time window, mechanical thrombectomy methods are mainly divided into two types. One is stent thrombectomy method. This method is punctured through the femoral artery, and the guide catheter system is pushed to the artery where the stroke occurs, and then the stent device is delivered through the lumen of the microcatheter. After crossing the thrombus, the thrombectomy stent is released, and the thrombus is pulled out through the stent to help restore blood flow and remove the thrombus that caused the stroke; the second is the suction catheter suction method, which delivers the suction catheter to the stroke-affected artery. At the proximal end of the thrombus, the negative pressure source is used to suck out the thrombus or plaque from the blocked blood vessel, so as to achieve the purpose of opening the blood vessel and restoring blood flow.

然而，虽然取栓法可以通过取栓支架或抽吸导管顺利快速恢复血管的畅通，但治疗后的血管会由闭塞瞬间转为通畅，动脉血的再灌注可能会造成脑的缺血-再灌注损伤，临床上常常出现血管再通后病情恶化或发生不可逆性脑死亡。在缺血时期局部稳态被打破，细胞能量代谢等重要功能结构被破坏，血管受损和微循环障碍，血脑屏障结构被破坏。再灌注时，破坏的结构与功能并未恢复，大量炎性细胞、大分子炎症因子通过受损的血脑屏障进入大脑，反而使损伤进一步加重。脑缺血-再灌注也可造成脑功能严重受损，脑缺血时脑细胞生物电发生改变，出现病理性慢波，而血管开通后的快速再灌注会使慢波持续并加重。此外，脑组织超微结构也会发生改变，包括线粒体肿胀、钙盐沉积，并可见线粒体嵴断裂、核染色质凝集、内质网高度肿胀，结构明显破坏、星型细胞肿胀，Nissl体完整性破坏、胶质细胞、血管内皮细胞肿胀，周围间隙增大并有淡红色水肿液、白质纤维间隙疏松，血管内由微血栓、髓鞘分层变性，呈现不可逆损伤。However, although the thrombectomy method can smoothly and quickly restore the patency of the blood vessels through the thrombectomy stent or suction catheter, the blood vessels after treatment will be instantly turned from occlusion to patency, and the reperfusion of arterial blood may cause cerebral ischemia-reperfusion. Injury, clinically, the disease often deteriorates or irreversible brain death occurs after vascular recanalization. During ischemia, local homeostasis is disrupted, important functional structures such as cellular energy metabolism are destroyed, blood vessels are damaged and microcirculation is disrupted, and the structure of the blood-brain barrier is destroyed. During reperfusion, the damaged structure and function are not restored, and a large number of inflammatory cells and macromolecular inflammatory factors enter the brain through the damaged blood-brain barrier, which further aggravates the damage. Cerebral ischemia-reperfusion can also cause serious damage to brain function. During cerebral ischemia, the bioelectricity of brain cells changes and pathological slow waves appear. Rapid reperfusion after vascular opening will make slow waves continue and aggravate. In addition, the ultrastructure of brain tissue also changes, including mitochondrial swelling, calcium salt deposition, and visible mitochondrial cristae, nuclear chromatin condensation, highly swollen endoplasmic reticulum, significantly damaged structure, astrocyte swelling, Nissl body integrity Destruction, glial cells, vascular endothelial cells swollen, the surrounding space increases with light red edema fluid, white matter fiber space loose, and the blood vessels are degenerated by microthrombi and myelin layers, showing irreversible damage.

然而，现有的方法都是基于栓塞开通后对脑组织的再灌注损伤的基础上再行预防和治疗；而最新的研究标明，通过放慢对缺血脑组织的再灌注过程，使其灌注缓慢、逐步增加，即血流阻断-开通-限流，可以有效减少脑水肿，降低血脑屏障破坏，降低出血转化，从而改善预后，减少并发症的出现。However, the existing methods are all based on the prevention and treatment of brain tissue reperfusion injury after embolization is opened. The latest research shows that by slowing down the reperfusion process of ischemic brain tissue, it can be perfused. Slow and gradual increase, that is, blood flow blocking-opening-flow restriction, can effectively reduce cerebral edema, reduce blood-brain barrier damage, and reduce hemorrhagic transformation, thereby improving prognosis and reducing the occurrence of complications.

因此，如何提供一种取栓术后能够对血流阻断和适当限流的球囊导管是本领域技术人员目前需要解决的技术问题。Therefore, how to provide a balloon catheter capable of blocking blood flow and appropriately restricting flow after thrombectomy is a technical problem that those skilled in the art need to solve at present.

发明内容SUMMARY OF THE INVENTION

本发明的目的是提供一种部分阻断血流的球囊导管，通过分别控制多个球囊的充气状态，实现对血管封闭状态的准确调整，从而实现对灌注血流的精确控制，从而促进大脑功能恢复。The purpose of the present invention is to provide a balloon catheter that partially blocks blood flow. By controlling the inflation state of a plurality of balloons respectively, the accurate adjustment of the closed state of the blood vessel is realized, so as to realize the precise control of the perfusion blood flow, thereby promoting the Brain function recovery.

为解决上述技术问题，本发明提供一种部分阻断血流的球囊导管，包括导管座和安装于所述导管座的管身，所述管身的近端节段连接所述导管座，所述管身的远端节段上设置有多个球囊，所述管身内部设置有轴向延伸的主孔道和相互隔绝的多个侧孔道，所述导管座上对应设置有主管和多个侧管，多个所述侧孔道分别连通不同的所述球囊，以分别控制多个所述球囊的充气状态。In order to solve the above-mentioned technical problems, the present invention provides a balloon catheter for partially blocking blood flow, comprising a catheter seat and a tube body installed on the catheter seat, and the proximal segment of the tube body is connected to the catheter seat, A plurality of balloons are arranged on the distal section of the tube body, an axially extending main channel and a plurality of side channels isolated from each other are arranged inside the tube body, and a main tube and a plurality of side channels are correspondingly arranged on the catheter holder. A plurality of side tubes are respectively connected with the different balloons, so as to control the inflation state of the multiple balloons respectively.

优选地，多个所述球囊沿螺旋线均匀排布于所述远端节段外周。Preferably, a plurality of the balloons are evenly arranged on the outer periphery of the distal segment along a helical line.

优选地，包括四个所述球囊，四个所述球囊在轴向上由所述近端节段与所述远端节段交汇处至所述远端节段末端依次排列，四个所述球囊在周向上相隔90度依次排列。Preferably, four balloons are included, and the four balloons are arranged in sequence from the intersection of the proximal segment and the distal segment to the end of the distal segment in the axial direction, and the four balloons are arranged in sequence in the axial direction. The balloons are arranged in sequence at a distance of 90 degrees in the circumferential direction.

优选地，包括两个所述侧孔道，一个所述侧孔道连通四个所述球囊中的两个，另一个所述侧孔道连通四个所述球囊中的另两个。Preferably, two side channels are included, one of the side channels communicates with two of the four balloons, and the other side channel communicates with the other two of the four balloons.

优选地，所述主孔道为所述管身沿轴线设置的内孔，两个所述侧孔道设置于所述内孔的孔壁上，并位于所述主孔道的两侧，所述侧孔道连通所述球囊的位置设置有第一通气孔，对应的两个所述球囊通过绕行设置的交通孔道相互连通。Preferably, the main channel is an inner hole arranged along the axis of the pipe body, and the two side channels are arranged on the hole wall of the inner hole and are located on both sides of the main channel. A first ventilation hole is provided at the position connecting the balloons, and the two corresponding balloons are communicated with each other through a detoured traffic channel.

优选地，所述导管座的所述主管与所述近端节段连接处套装有应力释放连接件，两个所述侧管设置于所述主管的两侧并向外展开，分别连通两个所述侧孔道，所述侧孔道的近端连通所述侧管的位置设置有第二通气孔。Preferably, the connection between the main pipe of the catheter holder and the proximal segment is sleeved with a stress-releasing connector, and the two side pipes are arranged on both sides of the main pipe and expand outward, respectively connecting the two side pipes. In the side channel, a second ventilation hole is provided at the position where the proximal end of the side channel communicates with the side tube.

优选地，所述近端节段的孔壁内设置有交错式编织加强层，所述远端节段的孔壁内设置有弹簧圈式编织加强层。Preferably, a staggered braided reinforcement layer is provided in the hole wall of the proximal segment, and a coil type braided reinforcement layer is provided in the hole wall of the distal segment.

优选地，所述球囊队列的前端和后端均设置有显影环。Preferably, both the front and rear ends of the balloon array are provided with developing rings.

优选地，所述管身的球囊段和导管段均具有顺应性，所述管身的内外壁及所述球囊外壁表面上设置有亲水涂层和肝素涂层。Preferably, both the balloon section and the catheter section of the tube body are compliant, and the inner and outer walls of the tube body and the surface of the outer wall of the balloon are provided with a hydrophilic coating and a heparin coating.

优选地，还包括留置固定器，所述留置固定器的一侧设置有粘性胶，所述留置固定器的另一侧设置有沟槽结构和卡扣，用于卡接并固定所述近端节段。Preferably, it also includes an indwelling fixture, one side of the indwelling fixture is provided with adhesive glue, and the other side of the indwelling fixture is provided with a groove structure and a buckle for clamping and fixing the proximal end Segments.

本发明提供一种部分阻断血流的球囊导管，包括导管座和安装于导管座的管身，管身的近端节段连接导管座，管身的远端节段上设置有多个球囊，管身内部设置有轴向延伸的主孔道和相互隔绝的多个侧孔道，导管座上对应设置有主管和多个侧管，多个侧孔道分别连通不同的球囊，以分别控制多个球囊的充气状态，球囊表面设有亲水涂层和肝素涂层，可有效避免球囊导管留置过程中表面的血栓形成。The invention provides a balloon catheter for partially blocking blood flow, comprising a catheter seat and a tube body mounted on the catheter seat, the proximal section of the tube body is connected to the catheter seat, and the distal section of the tube body is provided with a plurality of In the balloon, an axially extending main channel and a plurality of side channels isolated from each other are arranged inside the tube body, and a main tube and a plurality of side tubes are correspondingly arranged on the catheter holder, and the plurality of side channels are respectively connected to different balloons to control respectively. In the inflated state of multiple balloons, the surface of the balloon is provided with a hydrophilic coating and a heparin coating, which can effectively avoid the formation of thrombosis on the surface during the indwelling process of the balloon catheter.

通过多个球囊充气，有效对血栓近端血管进行封堵阻断保护，以降低开通早期的血流大量灌注，减少再灌注损伤并发症，并通过独立调节多个球囊的充气状态，以实现对血管封闭状态的多级别准确调整，从而实现对灌注血流的精确控制，从而促进大脑功能恢复，无需使用繁多的辅助器械，单一器械即可实现术中血流阻滞造影评估和短期冲管及液体灌注。By inflating multiple balloons, it can effectively block and block the proximal blood vessels of the thrombus, so as to reduce the massive perfusion of blood in the early stage of opening and reduce the complications of reperfusion injury. To achieve multi-level accurate adjustment of the closed state of blood vessels, so as to achieve precise control of perfusion blood flow, thereby promoting the recovery of brain function, without the use of many auxiliary instruments, a single instrument can achieve intraoperative blood flow block angiography assessment and short-term perfusion. Tube and fluid perfusion.

附图说明Description of drawings

图1为本发明所提供的球囊导管的一种具体实施方式的结构示意图；1 is a schematic structural diagram of a specific embodiment of a balloon catheter provided by the present invention;

图2为本发明所提供的球囊导管的一种具体实施方式的剖面示意图；2 is a schematic cross-sectional view of a specific embodiment of a balloon catheter provided by the present invention;

图3为本发明所提供的球囊导管的一种具体实施方式中球囊周向布置的位置示意图；3 is a schematic diagram of the position of the circumferential arrangement of the balloon in a specific embodiment of the balloon catheter provided by the present invention;

图4为本发明所提供的球囊导管的一种具体实施方式中近端节段的截面示意图；4 is a schematic cross-sectional view of a proximal segment in a specific embodiment of the balloon catheter provided by the present invention;

图5为图2中A处的局部放大图；Fig. 5 is the partial enlarged view of A place in Fig. 2;

图6为图2中B处的局部放大图；Fig. 6 is a partial enlarged view at B in Fig. 2;

图7为图2中C处的局部放大图；Fig. 7 is a partial enlarged view at C in Fig. 2;

图8为本发明所提供的球囊导管的一种具体实施方式中管身的结构示意图；8 is a schematic structural diagram of a tube body in a specific embodiment of the balloon catheter provided by the present invention;

图9为本发明所提供的球囊导管的一种具体实施方式中近端节段的结构示意图；9 is a schematic structural diagram of a proximal segment in a specific embodiment of the balloon catheter provided by the present invention;

图10为本发明所提供的球囊导管的一种具体实施方式中远端节段的结构示意图；10 is a schematic structural diagram of a distal segment in a specific embodiment of the balloon catheter provided by the present invention;

图11为本发明所提供的球囊导管的一种具体实施方式的球囊未充起示意图；Figure 11 is a schematic diagram of the balloon not inflated according to a specific embodiment of the balloon catheter provided by the present invention;

图12为本发明所提供的球囊导管的一种具体实施方式的球囊充起示意图。FIG. 12 is a schematic diagram of balloon inflation of a specific embodiment of the balloon catheter provided by the present invention.

具体实施方式Detailed ways

本发明的核心是提供一种部分阻断血流的球囊导管，通过分别控制多个球囊的充气状态，实现对血管封闭状态的准确调整，从而实现对灌注血流的精确控制，从而促进大脑功能恢复。The core of the present invention is to provide a balloon catheter that partially blocks blood flow. By separately controlling the inflation state of multiple balloons, accurate adjustment of the closed state of the blood vessel can be achieved, so as to achieve precise control of perfusion blood flow, thereby promoting Brain function recovery.

为了使本技术领域的人员更好地理解本发明方案，下面结合附图和具体实施方式对本发明作进一步的详细说明。In order to make those skilled in the art better understand the solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

请参考图1和图2，图1为本发明所提供的球囊导管的一种具体实施方式的结构示意图；图2为本发明所提供的球囊导管的一种具体实施方式的剖面示意图。Please refer to FIG. 1 and FIG. 2. FIG. 1 is a schematic structural diagram of a specific embodiment of the balloon catheter provided by the present invention; FIG. 2 is a cross-sectional schematic diagram of a specific embodiment of the balloon catheter provided by the present invention.

本发明具体实施方式提供一种部分阻断血流的球囊导管，包括导管座1和安装于导管座1的管身3，管身3分为近端节段3-1和远端节段3-2两部分，近端为操作端，远端为病灶端，近端节段3-1连接导管座1，远端节段3-2上设置有多个球囊4，管身3内部设置有轴向延伸的主孔道3-10和相互隔绝的多个侧孔道3-11，导管座1上对应设置有主管和多个侧管，多个侧孔道3-11分别连通不同的球囊4，以分别控制多个球囊4的充气状态。The specific embodiment of the present invention provides a balloon catheter for partially blocking blood flow, comprising acatheter base 1 and atube body 3 mounted on thecatheter base 1, and thetube body 3 is divided into a proximal segment 3-1 and a distal segment 3-2 has two parts, the proximal end is the operation end, the distal end is the lesion end, the proximal segment 3-1 is connected to thecatheter holder 1, the distal segment 3-2 is provided with a plurality ofballoons 4, and the inside of thetube body 3 An axially extending main channel 3-10 and a plurality of side channels 3-11 isolated from each other are provided, thecatheter holder 1 is correspondingly provided with a main tube and a plurality of side tubes, and the plurality of side channels 3-11 are respectively connected todifferent balloons 4, to control the inflation state of themultiple balloons 4 respectively.

其中，近端节段3-1至远端节段3-2的硬度设置为4至6段的多段式递减结构，管身3有效长度设置为80cm至130cm，近端节段3-1长度为65cm至95cm，远端节段3-2长度为25cm至35cm，优选的，管身3有效长度为95cm至105cm，近端节段3-1长度为70cm，远端节段3-2长度为30cm。The hardness of the proximal segment 3-1 to the distal segment 3-2 is set to a multi-segment decreasing structure with 4 to 6 segments, the effective length of thetube body 3 is set to 80 cm to 130 cm, and the length of the proximal segment 3-1 is set to It is 65cm to 95cm, the length of the distal segment 3-2 is 25cm to 35cm, preferably, the effective length of thetube body 3 is 95cm to 105cm, the length of the proximal segment 3-1 is 70cm, and the length of the distal segment 3-2 is 30cm.

进一步的，管身3外形可以为均匀粗细的圆柱形，也可为了增强近端节段3-1对远端节段3-2的支撑，将近端节段3-1的外径设置为略比远端节段3-2大，即首端细、尾端粗的圆锥形，近端节段3-1外径为5Fr至8Fr，远端节段3-2外径为3Fr至6Fr。优选的，若为圆柱形，则内外节段的外径为6Fr；若为圆锥形，近端节段3-1外径为6Fr，远端节段3-2外径为4Fr。另外，管身3的内径，即主孔道3-10的直径为3Fr，可通过直径为0.038inch及0.038inch以下的导丝。例如测压导丝，术后可供测压导丝进入，也可直接利用管腔测得颅内灌注压力，便于医师根据患者情况调节球囊4以控制颅内灌注量，使患者在取栓术后获得更好的恢复。或根据情况调整各部件的外形及尺寸参数，均在本发明的保护范围之内。Further, the outer shape of thetube body 3 can be cylindrical with uniform thickness, or in order to enhance the support of the proximal segment 3-1 to the distal segment 3-2, the outer diameter of the proximal segment 3-1 can be set to Slightly larger than the distal segment 3-2, that is, conical with a thin head and a thick tail, the outer diameter of the proximal segment 3-1 is 5Fr to 8Fr, and the outer diameter of the distal segment 3-2 is 3Fr to 6Fr . Preferably, if it is cylindrical, the outer diameter of the inner and outer segments is 6Fr; if it is conical, the outer diameter of the proximal segment 3-1 is 6Fr, and the outer diameter of the distal segment 3-2 is 4Fr. In addition, the inner diameter of thetube body 3, that is, the diameter of the main channel 3-10 is 3Fr, and a guide wire with a diameter of 0.038 inch or less can be passed through. For example, a manometry guide wire can be used to enter the manometry guide wire after operation, and the intracranial perfusion pressure can also be directly measured by the lumen, which is convenient for the doctor to adjust theballoon 4 according to the patient's condition to control the intracranial perfusion volume, so that the patient can be removed before the thrombectomy. Better recovery after surgery. Or adjust the shape and size parameters of each component according to the situation, all within the protection scope of the present invention.

工作时，由不同的侧孔道3-11向对应的球囊4充气，使部分球囊4充起或全部球囊4充起，进而通过多个球囊4充气，有效对血栓近端血管进行封堵阻断保护，以降低开通早期的血流大量灌注，减少再灌注损伤并发症，并通过独立调节多个球囊4的充气状态，以实现对血管封闭状态的多级别准确调整，从而实现对灌注血流的精确控制，从而促进大脑功能恢复，使用无需使用繁多的辅助器械，单一器械即可实现术中血流阻滞造影评估和短期冲管及液体灌注。When working, the correspondingballoons 4 are inflated from different side channels 3-11, so that part of theballoons 4 or all of theballoons 4 are inflated, and then inflated through a plurality ofballoons 4, which can effectively inflate the proximal blood vessels of the thrombus. Blocking and blocking protection to reduce the massive perfusion of blood flow in the early stage of opening, reduce the complications of reperfusion injury, and independently adjust the inflation state ofmultiple balloons 4 to achieve multi-level accurate adjustment of the blood vessel sealing state, so as to achieve Precise control of perfusion blood flow, thereby promoting the recovery of brain function, using a single instrument without the use of numerous auxiliary instruments to achieve intraoperative blood flow block angiography assessment and short-term flushing and fluid perfusion.

请参考图3至图7，图3为本发明所提供的球囊导管的一种具体实施方式中球囊周向布置的位置示意图；图4为本发明所提供的球囊导管的一种具体实施方式中近端节段的截面示意图；图5为图2中A处的局部放大图；图6为图2中B处的局部放大图；图7为图2中C处的局部放大图。Please refer to FIGS. 3 to 7 , FIG. 3 is a schematic diagram of the circumferential arrangement of the balloon in a specific embodiment of the balloon catheter provided by the present invention; FIG. 4 is a specific embodiment of the balloon catheter provided by the present invention. A schematic cross-sectional view of the proximal segment in the embodiment; FIG. 5 is a partial enlarged view of A in FIG. 2 ; FIG. 6 is a partial enlarged view of B in FIG. 2 ; FIG. 7 is a partial enlarged view of C in FIG. 2 .

为了提高控制的精确性，多个球囊4沿螺旋线均匀排布于远端节段3-2外周。也可采用其他排布方式，如沿直线排布成多列等。In order to improve the accuracy of control, a plurality ofballoons 4 are evenly arranged on the outer circumference of the distal segment 3-2 along the helical line. Other arrangements can also be used, such as arranging in multiple columns along a straight line.

具体地，可以设置四个球囊4，四个球囊4在轴向上由近端节段3-1与远端节段3-2的交汇处至远端节段3-2末端依次排列，四个球囊4在周向上相隔90度依次排列，使四个球囊4的连线呈螺旋线。也可适当增加球囊4的数量，排列更密集即可，缩小相邻两个球囊4的距离与角度差。球囊4具有顺应性，可通过注射等渗造影剂充盈至不同的大小，球囊4充盈膨大后，球囊4本身的顺应性也可以避免萎缩或塌陷，球囊导管的球囊段和导管段均具有顺应性，在球囊4未充盈时可随导管的行进而弯曲，以通过弯曲的血管区段，充气后有成型能力。Specifically, fourballoons 4 may be provided, and the fourballoons 4 are arranged in sequence in the axial direction from the intersection of the proximal segment 3-1 and the distal segment 3-2 to the end of the distal segment 3-2 , the fourballoons 4 are arranged in sequence at a distance of 90 degrees in the circumferential direction, so that the connection line of the fourballoons 4 is a spiral line. The number ofballoons 4 may also be appropriately increased, and the arrangement may be more dense, thereby reducing the distance and angle difference between twoadjacent balloons 4 . Theballoon 4 is compliant and can be inflated to different sizes by injecting isotonic contrast agents. After theballoon 4 is inflated and expanded, the compliance of theballoon 4 itself can also avoid shrinking or collapsing. The balloon segment of the balloon catheter and the catheter All segments are compliant, and can be bent along with the travel of the catheter when theballoon 4 is not inflated, so as to pass through the curved vessel segment, and have the ability to form after inflation.

为了实现分开单独控制，可以为每个球囊4单独设置一个侧孔道3-11，但是在实际操作过程中，并入需要过多的侧孔道3-11，可以只设置两个侧孔道3-11，一个侧孔道3-11连通四个球囊4中的两个，另一个侧孔道3-11连通四个球囊4中的另两个。四个球囊4两两相通，一个侧孔道3-11能够同时控制两个球囊4，即可实现多级控制，能够满足使用过程中的分级控制需求。四个球囊4的位置间隔为0.2cm至1cm，优选的间隔为0.5cm，球囊4区域总长度为1至3cm，优选的总长度为2cm。In order to achieve separate and independent control, one side channel 3-11 can be provided separately for eachballoon 4, but in the actual operation process, too many side channels 3-11 are required to be incorporated, and only two side channels 3-11 can be provided. 11. One side channel 3-11 communicates with two of the fourballoons 4, and the other side channel 3-11 communicates with the other two of the fourballoons 4. The fourballoons 4 are connected in pairs, and one side channel 3-11 can control the twoballoons 4 at the same time, so that multi-level control can be realized, which can meet the requirements of graded control during use. The position interval of the fourballoons 4 is 0.2 cm to 1 cm, and the preferred interval is 0.5 cm. The total length of theballoon 4 area is 1 to 3 cm, and the preferred total length is 2 cm.

进一步地，主孔道3-10为管身3内部沿轴线设置的内孔，两个侧孔道3-11设置于内孔的孔壁上，并位于主孔道3-10的两侧，侧孔道3-11连通球囊4的位置设置有第一通气孔3-12，对应的两个球囊4通过绕行设置的交通孔道相互连通。Further, the main channel 3-10 is an inner hole arranged along the axis inside thepipe body 3, and the two side channels 3-11 are arranged on the hole wall of the inner hole and are located on both sides of the main channel 3-10. -11 A first vent hole 3-12 is provided at the position where theballoon 4 is communicated, and the corresponding twoballoons 4 are communicated with each other through a detoured traffic hole.

相应的，近端节段3-1插入导管座1的主管，形成气密性连接，主管与近端节段3-1连接处套装有应力释放连接件2，提高连接稳定性，两个侧管设置于主管的两侧并向外倾斜展开，并分别连通两个侧孔道3-11，侧孔道3-11的近端连通侧管的位置设置有第二通气孔3-13，且主管和侧管之间设置有加强肋板。根据实际情况的需要，每个连接处均可以设置1至4个通气孔，优选地每个连接处均可以设置两个通气孔，保证进气量，实现快速充起。Correspondingly, the proximal section 3-1 is inserted into the main pipe of thecatheter holder 1 to form an airtight connection, and the connection between the main pipe and the proximal section 3-1 is sheathed with astress relief connector 2 to improve the connection stability. The pipes are arranged on both sides of the main pipe and are inclined outward, and are respectively connected with two side channels 3-11. A second vent hole 3-13 is provided at the position where the proximal end of the side holes 3-11 communicates with the side pipes, and the main pipe and the Reinforcing ribs are arranged between the side tubes. According to the needs of the actual situation, each connection can be provided with 1 to 4 ventilation holes, and preferably, each connection can be provided with two ventilation holes to ensure the intake air volume and realize fast charging.

侧管、第二通气孔3-13、侧孔道3-11和第一通气孔3-12共同形成了球囊4的充气腔道，通过注射器7连接测管，为设备充气。也采用其他结构的管身3，如套管结构等，均在本发明的保护范围之内The side tube, the second vent hole 3-13, the side channel 3-11 and the first vent hole 3-12 together form the inflation cavity of theballoon 4, and the measuring tube is connected through thesyringe 7 to inflate the device. Thepipe body 3 of other structures, such as the casing structure, etc., are also within the protection scope of the present invention.

请参考图8至图10，图8为本发明所提供的球囊导管的一种具体实施方式中管身的结构示意图；图9为本发明所提供的球囊导管的一种具体实施方式中近端节段的结构示意图；图10为本发明所提供的球囊导管的一种具体实施方式中远端节段的结构示意图。Please refer to FIGS. 8 to 10 , FIG. 8 is a schematic structural diagram of the tube body in a specific embodiment of the balloon catheter provided by the present invention; FIG. 9 is a specific embodiment of the balloon catheter provided by the present invention. Schematic diagram of the structure of the proximal segment; FIG. 10 is a schematic diagram of the structure of the distal segment in a specific embodiment of the balloon catheter provided by the present invention.

为了增强管身3近端节段3-1的操控传递和远端节段3-2的柔顺性，近端节段3-1的孔壁内设置有交错式编织加强层3-15，远端节段3-2的孔壁内设置有弹簧圈式编织加强层3-16，交汇处编织层结构为渐变式变化。通过内芯套管设计增强导管使用过程中的到位能力，提升了导管的支撑能力，能够顺利到达较远端的颅内血管。解决通管过程及留置过程中发生移位导致血管损伤、血流不可控的问题。In order to enhance the control transmission of the proximal segment 3-1 of thetube body 3 and the flexibility of the distal segment 3-2, a staggered braided reinforcing layer 3-15 is arranged in the hole wall of the proximal segment 3-1. A spring coil type braided reinforcing layer 3-16 is arranged in the hole wall of the end segment 3-2, and the structure of the braided layer at the intersection changes gradually. The inner core sleeve design enhances the ability of the catheter to be in place during use, improves the support ability of the catheter, and can smoothly reach the distal intracranial blood vessels. Solve the problem of vascular damage and uncontrollable blood flow caused by displacement during the process of catheterization and indwelling.

在本发明具体实施方式提供的球囊导管中，球囊4队列的前端和后端均设置有显影环3-14，明确定位球囊4区段的位置，便于使用过程中的探测和定位，便于在手术中标记操作区域。具体地，分别设置于第一个球囊4前端0.5cm处和第四个球囊4的后端0.5cm处。还可在远端节段3-2的末端设置尖端显影环3-17，定位末端的位置。In the balloon catheter provided by the specific embodiment of the present invention, the front and rear ends of theballoon 4 queues are provided with developing rings 3-14, which clearly locate the position of theballoon 4 segment, which is convenient for detection and positioning during use. Convenient for marking the operating area during surgery. Specifically, they are respectively arranged at 0.5 cm at the front end of thefirst balloon 4 and at 0.5 cm at the rear end of thefourth balloon 4 . A tip development ring 3-17 may also be provided at the tip of the distal segment 3-2 to locate the tip.

另外，管身3的内外壁及球囊4外壁表面上设置有亲水涂层和肝素涂层，避免血小板黏附导致的血栓形成，解决了长期置管术中血栓形成的问题，能在术后顺利放置1至2周。In addition, the inner and outer walls of thetube body 3 and the outer wall surface of theballoon 4 are provided with a hydrophilic coating and a heparin coating to avoid thrombosis caused by platelet adhesion, solve the problem of thrombosis during long-term catheterization, and can be used after surgery. It sits smoothly for 1 to 2 weeks.

在上述各具体实施方式提供的球囊导管中，还包括留置固定器，留置固定器的一侧设置有粘性胶，可使用粘贴固定于人体皮肤，留置固定器的另一侧设置有塑料材质的沟槽结构和卡扣，沟槽深度与导管外形一致，用来容纳导管，卡扣打开状态下可将导管嵌入，卡扣闭合状态下可限制导管的移动，但不会压闭内腔。也可采用其他类型固定器，如绑带、魔术贴等结构。避免导管移位造成的牵拉损伤，以达到留置1至2周的目的。The balloon catheter provided by the above-mentioned specific embodiments further includes an indwelling fixture, one side of the indwelling fixture is provided with adhesive glue, which can be pasted and fixed on human skin, and the other side of the indwelling fixture is provided with a plastic material. The groove structure and the buckle, the groove depth is consistent with the shape of the catheter, used to accommodate the catheter, the catheter can be embedded in the open state of the buckle, and the movement of the catheter can be restricted in the closed state of the buckle, but the inner cavity will not be compressed. Other types of fasteners can also be used, such as straps, Velcro and other structures. To avoid the traction injury caused by the displacement of the catheter, in order to achieve the purpose of indwelling for 1 to 2 weeks.

具体工作过程请参考图11和图12，图11为本发明所提供的球囊导管的一种具体实施方式的球囊未充起示意图；图12为本发明所提供的球囊导管的一种具体实施方式的球囊充起示意图。Please refer to FIG. 11 and FIG. 12 for the specific working process. FIG. 11 is a schematic diagram of an uninflated balloon of a specific embodiment of the balloon catheter provided by the present invention; FIG. 12 is a schematic diagram of the balloon catheter provided by the present invention. Schematic diagram of balloon inflation of a specific embodiment.

管身3伸入堵塞开通后的血管6，可明显发现血流5的变化情况，其中近端血管血流5-1变化不大，远端血管血流5-2在球囊4充起后明显变小。When thetube body 3 extends into the blocked and openedblood vessel 6, the change ofblood flow 5 can be clearly found. The blood flow 5-1 of the proximal blood vessel does not change much, and the blood flow of the distal blood vessel 5-2 is inflated after theballoon 4 is inflated. significantly smaller.

以上对本发明所提供的部分阻断血流的球囊导管进行了详细介绍。本文中应用了具体个例对本发明的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以对本发明进行若干改进和修饰，这些改进和修饰也落入本发明权利要求的保护范围内。The balloon catheter for partially blocking blood flow provided by the present invention has been described in detail above. The principles and implementations of the present invention are described herein by using specific examples, and the descriptions of the above embodiments are only used to help understand the method and the core idea of the present invention. It should be pointed out that for those skilled in the art, without departing from the principle of the present invention, several improvements and modifications can also be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

Claims (10)

Translated fromChinese

1.一种部分阻断血流的球囊导管，包括导管座(1)和安装于所述导管座(1)的管身(3)，所述管身(3)的近端节段(3-1)连接所述导管座(1)，所述管身(3)的远端节段(3-2)上设置有多个球囊(4)，其特征在于，所述管身(3)内部设置有轴向延伸的主孔道(3-10)和相互隔绝的多个侧孔道(3-11)，所述导管座(1)上对应设置有主管和多个侧管，多个所述侧孔道(3-11)分别连通不同的所述球囊(4)，以分别控制多个所述球囊(4)的充气状态。1. A balloon catheter for partially blocking blood flow, comprising a catheter holder (1) and a pipe body (3) installed in the catheter holder (1), the proximal segment ( 3-1) Connecting the catheter holder (1), the distal segment (3-2) of the tube body (3) is provided with a plurality of balloons (4), characterized in that the tube body ( 3) An axially extending main channel (3-10) and a plurality of side channels (3-11) isolated from each other are provided inside, and a main pipe and a plurality of side pipes are correspondingly arranged on the catheter holder (1). The side channels (3-11) are respectively connected with different balloons (4), so as to control the inflation state of the multiple balloons (4) respectively.2.根据权利要求1所述的部分阻断血流的球囊导管，其特征在于，多个所述球囊(4)沿螺旋线均匀排布于所述远端节段(3-2)外周。2 . The balloon catheter for partially blocking blood flow according to claim 1 , wherein a plurality of the balloons ( 4 ) are evenly arranged on the distal segment ( 3-2 ) along a spiral line. 3 . peripheral.3.根据权利要求2所述的部分阻断血流的球囊导管，其特征在于，包括四个所述球囊(4)，四个所述球囊(4)在轴向上由所述近端节段(3-1)与所述远端节段(3-2)交汇处至所述远端节段(3-2)末端依次排列，四个所述球囊(4)在周向上相隔90度依次排列。3. The balloon catheter for partially blocking blood flow according to claim 2, characterized in that it comprises four said balloons (4), and the four said balloons (4) are axially formed by said From the intersection of the proximal segment (3-1) and the distal segment (3-2) to the distal end of the distal segment (3-2), the four balloons (4) are arranged in sequence. Arranged 90 degrees apart.4.根据权利要求3所述的部分阻断血流的球囊导管，其特征在于，包括两个所述侧孔道(3-11)，一个所述侧孔道(3-11)连通四个所述球囊(4)中的两个，另一个所述侧孔道(3-11)连通四个所述球囊(4)中的另两个。4. The balloon catheter for partially blocking blood flow according to claim 3, characterized in that it comprises two said side holes (3-11), and one said side hole (3-11) communicates with four said side holes (3-11) Two of the balloons (4), and the other side channel (3-11) communicates with the other two of the four balloons (4).5.根据权利要求4所述的部分阻断血流的球囊导管，其特征在于，所述主孔道(3-10)为所述管身(3)沿轴线设置的内孔，两个所述侧孔道(3-11)设置于所述内孔的孔壁上，并位于所述主孔道(3-10)的两侧，所述侧孔道(3-11)连通所述球囊(4)的位置设置有第一通气孔(3-12)，对应的两个所述球囊(4)通过绕行设置的交通孔道相互连通。5. The balloon catheter for partially blocking blood flow according to claim 4, characterized in that, the main hole (3-10) is an inner hole provided along the axis of the pipe body (3), and the two The side channels (3-11) are arranged on the hole wall of the inner hole and are located on both sides of the main channel (3-10), and the side channels (3-11) communicate with the balloon (4). ) is provided with a first vent hole (3-12), and the two corresponding balloons (4) are communicated with each other through a detoured traffic channel.6.根据权利要求5所述的部分阻断血流的球囊导管，其特征在于，所述导管座(1)的所述主管与所述近端节段(3-1)连接处套装有应力释放连接件(2)，两个所述侧管设置于所述主管的两侧并向外展开，分别连通两个所述侧孔道(3-11)，所述侧孔道(3-11)的近端连通所述侧管的位置设置有第二通气孔(3-13)。6 . The balloon catheter for partially blocking blood flow according to claim 5 , wherein the connection between the main pipe of the catheter holder ( 1 ) and the proximal segment ( 3 - 1 ) is sheathed with a sleeve. 7 . A stress relief connector (2), the two side pipes are arranged on both sides of the main pipe and spread out, respectively connecting the two side channels (3-11), the side channels (3-11) A second vent hole (3-13) is provided at the position where the proximal end of the duct communicates with the side tube.7.根据权利要求6所述的部分阻断血流的球囊导管，其特征在于，所述近端节段(3-1)的孔壁内设置有交错式编织加强层(3-15)，所述远端节段(3-2)的孔壁内设置有弹簧圈式编织加强层(3-16)。7. The balloon catheter for partially blocking blood flow according to claim 6, wherein a staggered braided reinforcing layer (3-15) is provided in the hole wall of the proximal segment (3-1) , a coil type braided reinforcing layer (3-16) is arranged in the hole wall of the distal segment (3-2).8.根据权利要求2所述的部分阻断血流的球囊导管，其特征在于，所述球囊(4)队列的前端和后端均设置有显影环(3-14)。8 . The balloon catheter for partially blocking blood flow according to claim 2 , wherein the front and rear ends of the balloon ( 4 ) queue are provided with developing rings ( 3 - 14 ). 9 .9.根据权利要求1所述的部分阻断血流的球囊导管，其特征在于，所述管身(3)的球囊段和导管段均具有顺应性，所述管身(3)的内外壁及所述球囊(4)外壁表面上设置有亲水涂层和肝素涂层。9. The balloon catheter for partially blocking blood flow according to claim 1, characterized in that both the balloon section and the catheter section of the tube body (3) are compliant, and the tube body (3) has compliance. A hydrophilic coating and a heparin coating are arranged on the inner and outer walls and the outer wall surface of the balloon (4).10.根据权利要求1至9任意一项所述的部分阻断血流的球囊导管，其特征在于，还包括留置固定器，所述留置固定器的一侧设置有粘性胶，所述留置固定器的另一侧设置有沟槽结构和卡扣，用于卡接并固定所述近端节段(3-1)。10. The balloon catheter for partially blocking blood flow according to any one of claims 1 to 9, characterized in that it further comprises an indwelling fixture, one side of the indwelling fixture is provided with adhesive glue, and the indwelling fixture is provided with adhesive glue. The other side of the fixer is provided with a groove structure and a buckle for clamping and fixing the proximal segment (3-1).

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